Annalise Enterprise CXR Triage Trauma

by Annalise-AI Pty  · Based in Australia → — Fusing the highest quality imaging data with the very best in computer science to produce comprehensive AI clinical decision support solutions, empowering clinicians to make accurate, faster decisions.
Critical Care Emergency Medicine Radiology
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Regulatory Status Disclosed

Overview

Annalise Enterprise CXR Triage Trauma: AI-Powered Chest X-ray Triage

Annalise Enterprise CXR Triage Trauma is a software workflow tool developed by Annalise-AI Pty, designed to enhance the clinical assessment of adult chest X-ray (CXR) cases. This AI-powered solution utilizes a convolutional neural network trained with deep-learning techniques on extensive datasets, including nearly a million chest X-rays, to identify suspected radiological findings. It acts as a ‘second pair of eyes’ for clinicians, aiding in critical triage and diagnostics, especially in high-pressure environments.

The device analyzes CXR studies to identify features suggestive of conditions such as pleural effusion and pneumoperitoneum, and can detect up to 124 findings, including pneumothorax, lung nodules, pneumomediastinum, and various fractures (ribs, clavicle, humerus). It makes case-level output available to a Picture Archiving and Communication System (PACS) or Radiology Information System (RIS) for worklist prioritization or triage, ensuring urgent cases are reviewed earlier without decreasing the priority of other studies.

Annalise Enterprise CXR Triage Trauma is intended for use by trained clinicians qualified to interpret chest X-rays as part of their scope of practice. It integrates seamlessly into existing workflows, improving reporting accuracy and efficiency. The tool is part of Annalise-AI’s broader Enterprise suite, which also includes solutions for CT Brain, offering a comprehensive AI platform for radiology departments.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-enhanced worklist prioritization and triage for CXRs
  • Detection of up to 124 suspected radiological findings on chest X-rays
  • Identification of pleural effusion and pneumoperitoneum for trauma triage
  • Seamless integration with existing PACS/RIS systems
  • Localization of specific findings on images
  • Improved reporting accuracy and efficiency for radiologists
  • Acts as a 'second pair of eyes' for clinicians
  • Supports adult patient populations (16+ years for CXR)
  • Optional Annalise Web Viewer for AI results display
  • Does not decrease existing study priority in worklist

Use Cases

  • Rapid triage of critical chest X-ray cases in emergency settings
  • Assisting clinicians with interpretation of complex CXR studies
  • Improving diagnostic accuracy and reducing missed findings
  • Optimizing radiology workflow efficiency and reporting times
  • Identifying subtle findings such as small pneumothoraxes or rib fractures
  • Supporting the detection of undiagnosed conditions like osteoporosis via vertebral compression fractures

What Physicians Need to Know

DICOM Support & Standards
Annalise Enterprise CXR Triage Trauma interfaces with image and order management systems (PACS/RIS) to obtain and process DICOM-compliant chest X-ray (CXR) studies. It supports DICOM capabilities for both inputs and outputs, identifying suspected findings in digitized (CR) or digital (DX) CXR exams.
PACS Integration Method
The device seamlessly integrates directly within existing PACS/RIS systems. It obtains CXR studies for processing and provides case-level output or notifications to the PACS or RIS for worklist prioritization or triage. The Annalise Viewer, a desktop application, can receive study details from the PACS viewer and display AI results.
Reading Room Workflow Impact
Designed as a software workflow tool to aid clinical assessment, it enables earlier review of cases with features suggestive of critical findings by prioritizing them in the worklist. It operates in parallel with the standard clinical workflow, never decreasing a study's existing priority, aiming to improve efficiency and provide a 'second pair of eyes'.
AI Model Architecture (deep learning approach)
The AI algorithm is a convolutional neural network trained using deep-learning techniques. It was trained on one of the world's largest radiologist hand-annotated chest X-ray datasets, comprising over 782,000 unique CXR studies with more than 280,000,000 individual annotations by at least three radiologists.
Processing Speed (per study)
While specific data for CXR Triage Trauma was not explicitly found, a related Annalise Enterprise CTB Triage Trauma device demonstrated a triage turn-around time of 42.3 seconds (95% CI: 41.2, 43.4), which was comparable to predicate devices.
FDA Clearance Pathway (510k/De Novo)
Annalise Enterprise CXR Triage Trauma has received multiple 510(k) clearances from the U.S. FDA. It is classified as Radiological computer aided triage and notification software (21CFR892.2080), Regulatory Class II.
Supported Modalities (CT/MRI/X-ray/US)
This specific tool, Annalise Enterprise CXR Triage Trauma, supports Chest X-ray (CXR) modality. It processes digitized (CR) or digital (DX) chest X-ray exams, including anterior-posterior (AP), posterior-anterior (PA), and optionally lateral (LAT) orientations.
Sensitivity & Specificity Data
For vertebral compression fracture, the model achieved a sensitivity of 89.3% (95% CI: 85.7%-92.7%) and a specificity of 89.2% (95% CI: 85.4%-92.3%). In trauma CXRs, the AI showed superior performance to radiologists for pneumothorax and segmental collapse, and comparable performance for rib fractures and pneumomediastinum, with high specificity (>95%) across pathologies. AI-assisted radiologist accuracy was non-inferior in 95% of findings and better in 80%.
RSNA/ACR Validation
While the device's performance has been validated in standalone retrospective studies by US board-certified radiologists and presented at events like RSNA, there is no explicit mention of formal 'RSNA/ACR Validation' as a specific program or certification for this product in the provided information.
Physician Tip

Annalise Enterprise CXR Triage Trauma is a workflow aid for clinical assessment and worklist prioritization, not a standalone diagnostic tool. Clinicians retain ultimate responsibility for interpretation and must concurrently review AI output with original images and all relevant clinical data. The AI is designed to enhance efficiency and accuracy by acting as a 'second pair of eyes' and will never downgrade a study's existing priority.

The solution offers seamless integration with existing PACS and RIS systems, allowing it to obtain studies for processing and provide output for worklist prioritization and triage. It can be launched directly from either platform, and the Annalise Viewer can display AI results in conjunction with the PACS viewer.

Details

Category Radiology & Imaging AI, Triage & ER/ICU AI
Pricing Contact for pricing
DeploymentHybrid (primarily on-premise integration with PACS/RIS, with optional web viewer)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

Annalise Enterprise CXR Triage Trauma received FDA 510(k) clearance (K222179) on February 24, 2023, for aiding in the clinical assessment of adult chest X-ray cases with features suggestive of pleural effusion and pneumoperitoneum. Annalise.ai has multiple FDA clearances, including for other CXR findings and non-contrast head CT findings.
Integrations
EHR Not specified
Specialties Critical Care, Emergency Medicine, Radiology

What the Web Says

Annalise Enterprise CXR Triage Trauma is an AI-powered software tool designed to assist clinicians in interpreting chest X-rays, particularly in trauma and emergency settings. It aims to improve diagnostic accuracy, efficiency, and workflow by identifying suspected critical findings and prioritizing urgent cases. The tool detects a comprehensive range of findings (up to 124 for CXR) and integrates with existing PACS/RIS systems.

Overall: Positive

Strengths

  • Enhances diagnostic accuracy and reduces missed diagnoses, especially for subtle findings like small pneumothoraxes and rib fractures.
  • Improves efficiency and reduces turnaround time for critical cases by prioritizing worklists.
  • Seamlessly integrates with existing radiology workflows and IT systems (PACS/RIS).
  • Acts as a 'second pair of eyes,' providing a consistent and tireless review, which is beneficial for clinicians dealing with fatigue and high workloads.
  • Comprehensive detection of up to 124 clinical findings on chest X-rays, exceeding many other AI products.
  • Validated through extensive trials and studies, demonstrating comparable or superior performance to radiologists in certain aspects.

Limitations

  • Can produce false positives, leading to additional time spent by radiologists explaining them to other doctors and patients.
  • Some radiologists on Reddit have noted that the AI can miss things and overcall others.
  • One study indicated that while it outperformed radiologists in detecting pneumothorax and segmental collapse, it was inferior for clavicle, humerus, and scapula fractures.
  • The device is not intended to provide direct diagnosis; clinicians retain ultimate responsibility for interpretation.
  • Not intended for use on patients under 16 years of age for CXR.

Based on reviews from: ProvenExpert, YouTube (Annalise AI Enterprise CXR solution - An overview), accessdata.fda.gov (April 23, 2025 submission), accessdata.fda.gov (March 28, 2023 submission), Microsoft Marketplace, Annalise Enterprise - Administration Guide, Reddit (r/Radiology), Slashdot, PubMed (The Potential Clinical Utility of an Artificial Intelligence Model for Identification of Vertebral Compression Fractures in Chest Radiographs), Annalise.ai Radiologist package, PMC (Evaluating the impact of AI assistance on decision-making in emergency doctors interpreting chest X-rays: a multi-reader multi-case study), MDA Tech, The Royal College of Radiologists, PMC (Artificial Intelligence-Based Software with CE Mark for Chest X-ray Interpretation: Opportunities and Challenges), YouTube (How Annalise.ai is Transforming Radiology at Bradford Teaching Hospitals), PMC (Diagnostic accuracy of a commercially available deep-learning algorithm in supine chest radiographs following trauma), NeuroNews, Imaging Technology News, ResearchGate, Harrison.ai, Annalise.ai Introduces Radiology Triage Platform for Head CT and Chest X-Ray Exams, Study Reveals New Comprehensive AI Chest X-ray Solution Improves Radiologist Accuracy, Diagnostic Imaging

Last updated: 2026-07-19

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Press & Coverage

PMC - NIH
AI for Lesion Detection in Musculoskeletal Radiology
Annalise Enterprise CXR Triage Trauma is an AI software that detects vertebral compression fractures in posterior-anterior chest radiographs and has received CE certification and regulatory approval in Asia and Oceania.
2025-09
accessdata.fda.gov
Annalise Enterprise CXR Triage Trauma 510(k) Clearance (K222179)
This FDA 510(k) clearance document details Annalise Enterprise CXR Triage Trauma as a software workflow tool designed to aid in the clinical assessment of adult chest X-ray cases for vertebral compression fractures, pleural effusion, and pneumoperitoneum.
2023-03
PubMed
The Potential Clinical Utility of an Artificial Intelligence Model for Identification of Vertebral Compression Fractures in Chest Radiographs
A retrospective study assessed the Annalise Enterprise CXR Triage Trauma AI model's ability to identify vertebral compression fractures on chest radiographs, demonstrating high accuracy and potential for identifying undiagnosed osteoporosis.
2024-09
BEUDAMED
Annalise Enterprise CTB Triage Trauma
This entry lists Annalise Enterprise CXR Triage Trauma with its regulation number and FDA clearance date, categorizing it as radiological computer aided triage and notification software.
2023-04
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing
Annalise Enterprise CXR Triage Trauma is cited as an example of AI/ML SaMD where ground truth was established by multiple ABR-certified radiologists for chest X-ray cases.
2025-09
Innolitics
Command Line as a Medical Device (CLaMD)
Annalise Enterprise CXR Triage Trauma is mentioned as a software that interfaces with PACS/RIS systems, analyzes images, and provides case-level output for worklist prioritization or triage, operating in the background without its own direct user interface.
2025-05
unknown
Applications of AI/ML in accelerating the development of pulmonary drug delivery system
Annalise Enterprise CXR Triage Trauma is listed with its FDA approval date of March 28, 2023, for pleural effusion and pneumoperitoneum detection on CXR.
2023-03

Videos

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Frequently Asked Questions

Annalise Enterprise CXR Triage Trauma is an AI-powered software tool designed to assist clinicians by identifying suspected critical findings on adult chest X-rays, such as pleural effusion, pneumoperitoneum, pneumothorax, tension pneumothorax, and vertebral compression fractures. It integrates with existing PACS/RIS systems to prioritize radiology worklists, flagging urgent cases for earlier review without altering a study's original priority, thereby acting as a 'second pair of eyes' to improve reporting speed and accuracy.
Yes, Annalise Enterprise CXR Triage Trauma has received FDA 510(k) clearances and is classified as a Class II medical device. Users must adhere to general controls provisions, including Quality System (QS) regulations, proper labeling, and medical device reporting requirements.
The device is intended to *aid* clinical assessment and triage, not to provide a direct diagnosis or replace the clinician's ultimate responsibility for interpretation. While generally accurate, studies indicate that human radiologists may still outperform the AI for detecting certain specific fractures (e.g., clavicle, humerus, scapula) in trauma settings. Additionally, it is not intended for use on patients under 16 years of age for CXR.
Annalise Enterprise CXR Triage Trauma has demonstrated high accuracy, with its AI model alone being significantly more accurate than unassisted radiologists for many clinical findings and non-inferior for others. For specific findings like vertebral compression fractures, it has shown a sensitivity of 89.3% and specificity of 89.2%. When used as an assist device, it has been shown to improve radiologist accuracy by 45% and speed reporting time by 12% across all findings.
Key alternatives in the chest X-ray AI triage market include Lunit INSIGHT CXR, Qure.ai qXR, and Aidoc. Annalise Enterprise CXR Triage Trauma differentiates itself by offering a comprehensive suite of FDA-cleared findings for triage and notification on chest X-ray, including pneumothorax, tension pneumothorax, pleural effusion, pneumoperitoneum, and vertebral compression fracture.
The Annalise Enterprise system is designed to integrate securely within a hospital's existing IT infrastructure, such as PACS, and operates in conjunction with medical imaging viewer software. While specific technical details on data handling are often proprietary, the company emphasizes the importance of privacy, confidentiality of clinical information, and data protection in relevant jurisdictions.
While specific pricing for the CXR Triage Trauma product is not publicly detailed, Annalise.ai typically offers its enterprise solutions via a subscription-based model, with an annual cost for institutions. For a related product (Annalise Enterprise CTB Triage - OH), there is evidence of a new technology add-on payment (NTAP) from Medicare, suggesting potential reimbursement pathways for such AI triage solutions.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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